Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Bellerophon, Medicinova, Mesoblast, Regeneron.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Artios, Awkn, Biomedical Research & Bio-Products, Cara, Celyad, Cognition, Eiger, Galapagos, Immvira, Kite, Kura, Nexcella, Redx..
Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s experimental COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) 23% on Feb. 9 as the company continues to seek regulatory approval. That approval path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA.
Japan's National Center for Global Health and Medicine (NCGM) has divulged 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infections (COVID-19).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Biogen, Bioxytran, Egret, Endogena, Gilead, Hinova, Inmagene, Neogap, Neurosense, Sage, Sandoz, Takeda.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Calliditas, GSK, Pfizer, Pharmather, Pliant, Y-mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agomab, Amylyx, Anaveon, Anavex, Arrowhead, Artelo, Aulos, Biophytis, Clearside, Exscientia, First Wave, Inovio, Moonlake, Nrx, Oligomerix.
Tonix Pharmaceuticals Holding Corp. has announced it plans to develop the TNX-3900 series of oral antivirals as monotherapy or in combination with other antivirals, following an agreement whereby it has acquired all of the assets of Healion Bio Inc., including its entire portfolio of next-generation antiviral technology assets.